Back to results14 Weeks Exercise Training on Lean Women With and Without PCOS
Primary Purpose
Polycystic Ovary Syndrome (PCOS)
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
14 weeks exercise training
Sponsored by
About this trial
This is an interventional basic science trial for Polycystic Ovary Syndrome (PCOS) focused on measuring Polycystic Ovary Syndrome (PCOS)
Eligibility Criteria
Inclusion Criteria: Women with PCOS
- Hyperandrogenism and/or hyperandrogenemia
- Regular menstruation
- Age: 20-40
- Inactive or low physical activity level
- Low to moderate fitness status
Inclusion Criteria: Women without PCOS
- Normal levels of plasma androgens
- Polycystic ovary and/or menstrual dysfunction
- Age: 20-40
- Inactive or low physical activity level
- Low to moderate fitness status
Exclusion Criteria: Women with and without PCOS
- Pregnancy or breast feeding
- Smoking
- Use of birth control pills 3 mo before enrolment
Sites / Locations
- August Krogh Building
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Lean PCOS training
Lean healthy controls
Arm Description
14 weeks exercise training
14 weeks exercise training
Outcomes
Primary Outcome Measures
Compliance to exercise training program as assessed by number of training sessions completed
Superviced training program - no. of training sessions are noted by trainer. Compliance must be higher than 80%.
No change in Body Weight
Component of metabolic syndrome
Hole body insulin sensitivity measured by HOMA index
Component of metabolic syndrome
Peripheral insulin sensitivity measured by hyperinsulinemic euglycemic clamp methods.
Secondary Outcome Measures
Full Information
NCT ID
NCT02429128
First Posted
April 15, 2015
Last Updated
August 2, 2016
Sponsor
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT02429128
Brief Title
14 Weeks Exercise Training on Lean Women With and Without PCOS
Official Title
14 Weeks Exercise Training on Lean Women With and Without PCOS
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this project is to investigate the pathophysiology of PCOS in regards to the metabolic profile including defects in insulin sensitivity in skeletal muscle and adipose tissue, and to investigate the effects of exercise training on these parameters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome (PCOS)
Keywords
Polycystic Ovary Syndrome (PCOS)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lean PCOS training
Arm Type
Active Comparator
Arm Description
14 weeks exercise training
Arm Title
Lean healthy controls
Arm Type
Other
Arm Description
14 weeks exercise training
Intervention Type
Other
Intervention Name(s)
14 weeks exercise training
Primary Outcome Measure Information:
Title
Compliance to exercise training program as assessed by number of training sessions completed
Description
Superviced training program - no. of training sessions are noted by trainer. Compliance must be higher than 80%.
Time Frame
14 weeks
Title
No change in Body Weight
Time Frame
14 weeks
Title
Component of metabolic syndrome
Description
Hole body insulin sensitivity measured by HOMA index
Time Frame
14 weeks
Title
Component of metabolic syndrome
Description
Peripheral insulin sensitivity measured by hyperinsulinemic euglycemic clamp methods.
Time Frame
14 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women with PCOS
Hyperandrogenism and/or hyperandrogenemia
Regular menstruation
Age: 20-40
Inactive or low physical activity level
Low to moderate fitness status
Inclusion Criteria: Women without PCOS
Normal levels of plasma androgens
Polycystic ovary and/or menstrual dysfunction
Age: 20-40
Inactive or low physical activity level
Low to moderate fitness status
Exclusion Criteria: Women with and without PCOS
Pregnancy or breast feeding
Smoking
Use of birth control pills 3 mo before enrolment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bente Kiens, Professor
Organizational Affiliation
NEXS, KU
Official's Role
Study Director
Facility Information:
Facility Name
August Krogh Building
City
Copenhagen
State/Province
Østerbro
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
30544235
Citation
Hansen SL, Svendsen PF, Jeppesen JF, Hoeg LD, Andersen NR, Kristensen JM, Nilas L, Lundsgaard AM, Wojtaszewski JFP, Madsbad S, Kiens B. Molecular Mechanisms in Skeletal Muscle Underlying Insulin Resistance in Women Who Are Lean With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2019 May 1;104(5):1841-1854. doi: 10.1210/jc.2018-01771.
Results Reference
derived
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14 Weeks Exercise Training on Lean Women With and Without PCOS
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